XML 32 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
INTANGIBLE ASSETS
9 Months Ended
Sep. 30, 2013
Notes to Financial Statements  
Note 3. INTANGIBLE ASSETS

 The Company’s intangible assets are related to the acquisition of certain assets related to AzoneTS-based technology from Durham Pharmaceuticals Ltd. in 2007.  Following the acquisition in 2007, the Company has modestly advanced the development programs for DurhalieveTM for the treatment of corticosteroid-responsive dermatoses and for the early stage AzoneTS reformulation drug candidates. Among other things, the Company has monitored stability on new drug formulations, worked on a complete response on the Durhalieve New Drug Application, met with the FDA on  development status, assembled a response for the methotrexate-AzoneTS ‘end of Phase 2’ meeting with the FDA, engaged consultants to review and recommend new product candidates and formulations, and conducted partnering activities around the technology.  In addition, the Company has made applicable regulatory filings necessary to maintain the active status of the AzoneTS Drug Master File, the Durhalieve and MAZ Investigational New Drug applications and the MAZ Orphan Drug application with the FDA.

 

 As of September 30, 2013 and 2012, intangible assets related to this Acquisition are summarized as follows:

 

            2013     2012  
  Estimated         Accumulated              
  Life   Cost     Amortization     Net     Net  
Contract related intangible asset:                          
Cato Research discounted contract 3 years   $ 355,000     $ 355,000     $     $  
Technology related intangible assets:                                  
Patents for the AzoneTS-based product candidates and formulation 4.5 years     1,305,000             1,305,000       1,305,000  
Drug Master Files containing formulation, clinical and safety documentation used by the FDA 4.5 years     1,500,000             1,500,000       1,500,000  
In-process pharmaceutical products for 2 indications 4.5 years     6,820,000             6,820,000       6,820,000  
Total technology related intangible assets       9,625,000             9,625,000       9,625,000  
Total, net     $ 9,980,000     $ 355,000     $ 9,625,000     $ 9,625,000  

 

 Intangible assets related to technology are expected to be amortized on a straight-line basis over the period ending 2019, when the underlying patents expire, and will commence upon revenue generation which the Company estimates could occur as early as the middle of 2015.  The Cato Research contract included above was amortized over a three year period, which ended in 2010.

 

 Estimated amortization expense for each of the next five calendar years is as follows:

 

 

 

 

 

Estimated

Amortization

Expense

 
2013   $  
2014      
2015     1,069,000  
2016     2,139,000  
2017     2,139,000  

 

 In periodically reviewing the carrying value of intangible assets, the Company considered if there have been events or circumstances that would indicate that the carrying amount of the intangible assets may not be recoverable.  If such events or circumstances existed, the Company performed an impairment test in accordance with FASB ASC 360-10. Under that standard, the first step in the impairment analysis is to compare the undiscounted cash flows to the carrying value of the intangibles.  The project’s undiscounted cash flows exceeded the carrying value at each of the Company’s assessment dates following acquisition, including December 31, 2012.  As a result, it was not necessary for the Company to conduct further analysis or to make a determination of the fair value of the intangible assets and thereby the Company concluded that there was no impairment.  It is the Company’s policy to evaluate intangible assets for impairment at least annually in connection with its year end financial statement preparation.